MAUDE Adverse Event Report: S.B.M. SAS COMPOSITCP 60; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	905257
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an initial hamstring tendon graft procedure, two interference screws fractured.Half of one screw remains in the patient's bone tunnel and is indicated to be stable without the potential for migration.The surgeon stated that removing it was not possible, and the case was completed with a bone post outside the tunnel for graft fixation.The correct surgical technique was used.No other complications or impacts were reported due to this malfunction.Attempts have been made, and no further information has been provided.

• Brand Name: COMPOSITCP 60
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): S.B.M. SAS; zi du monge; lourdes 65100 ; FR 65100
• MDR Report Key: 20370650
• Report Number: 0001825034-2024-02336
• Device Sequence Number: 3889895
• Product Code: MAI
• UDI-Device Identifier: 03760154006675
• UDI-Public: (01)03760154006675(17)270201(10)240534
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2024
• Report Date (Section F): 08/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 905257
• Device Lot Number: 240534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART 905604, LOT 544900
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/29/2024